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Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer

NCT ID: NCT06816979

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-10-31

Brief Summary

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This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine if CSF-ctDNA positivity in patients with locally advanced lung cancer can predict the presence of brain metastases within a one year period.

II. To prospectively confirm that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) can be detected in patients diagnosed with metastatic non-small cell lung cancer (NSCLC) to the brain utilizing next generation sequencing (NGS) and single gene quantitative/biomarker analyses through the CNSide (trademark) platform.

SECONDARY OBJECTIVES:

I. To use the CNSide (trademark) platform to assess for the presence of circulating tumor cells in both CSF and peripheral blood.

II. To compare the NGS profile of the ct-DNA in the CSF with matched peripheral blood samples.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1 (STAGE III/IV NSCLC WITHOUT BRAIN METASTASES): Patients undergo lumbar puncture (LP) for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo magnetic resonance imaging (MRI) during screening and 12 month follow-up.

COHORT 2 (STAGE IV NSCLC WITH BRAIN METASTASES): Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.

Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Patients without brain metastases are followed for 12 months. Patients with brain metastases are followed for 6 months.

Conditions

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Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cohort 1: Stage III/IV without brain metastases (LP)

Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up.

Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Lumbar Puncture

Intervention Type PROCEDURE

Undergo LP

Magnetic Resonance Imaging

Intervention Type DEVICE

Undergo MRI

Cohort 2: Stage IV NSCLC with brain metastases (LP)

Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.

Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Lumbar Puncture

Intervention Type PROCEDURE

Undergo LP

Magnetic Resonance Imaging

Intervention Type DEVICE

Undergo MRI

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Lumbar Puncture

Undergo LP

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type DEVICE

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection LP Spinal Tap Magnetic Resonance Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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Inclusion Criteria

* New histological diagnosis of stage III or IV NSCLC
* For stage III/IV NSCLC patients without brain metastases, a documented mutation on lung cancer mutation panel (PULMOL) is required
* Patient treated with radiation therapy and/or systemic therapy at Ohio State University
* Estimated survival \>= 1 year
* No medical contraindication to lumbar puncture

Exclusion Criteria

* Patient has Alzheimer's, dementia, or mental disability
* Patient is not able to receive MRI
* Patient has allergy to xylocaine or any numbing medication for lumbar puncture
* Previous cancer history prior to diagnosis of NSCLC
* Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation required for standard of care treatment has unknown effects on the unborn fetus
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Joshua Palmer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua D Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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The Ohio State Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

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Joshua D. Palmer, MD

Role: primary

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2023-03242

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-22032

Identifier Type: -

Identifier Source: org_study_id